NOXXON Initiates Phase IIa Study of Anti-Hepcidin Spiegelmer Lexaptepid Pegol (NOX-H94)
NOXXON Pharma announced the treatment of a first patient with its anti-hepcidin Spiegelmer® lexaptepid pegol (NOX-H94) in a phase IIa proof - of - concept clinical trial to treat erythropoietin (EPO) - hyporesponsive anemia in dialysis patients. This is the fourth clinical trial with lexaptepid pegol. The multi-center, placebo - controlled study will examine the pharma cokinetics, pharmacodynamics, efficacy and safety of single and multiple doses of lexaptepid pegol in EPO - hyporesponsive dialysis patients with anemia.
Approximately 10% of the dialysis population has erythropoiesis - stimulat ingagent (ESA)-resistant anemia, an unmet medical need th at NOXXON now addresses with thi s study. A nemic dialysis patients that do not respond adequately to an ESA could benefit from the inhibition of hepcidin by lexaptepid pegol. A recent study by NOXXON, presented at the AACR meeting and the EHA congress in 2014, has already shown significant increases in hemoglobin levels (>1 g/dL) in response to lexaptepid pegol monotherapy in a subset of anemic cancer patients.
Lexaptepid pegol is a Spiegelmer® that binds and neutralizes hepcidin, a peptide hormone that negatively regulates serum iron levels. High hepcidin levels, commonly fo und in dialysis patients, lead to iron restriction, also known as functional iron deficiency. This condition, in which iron is blocked inside its cellular stores and therefore un available for hemoglobin synthesis, ultimately results in anemia.
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